FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD).
The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted, prior to resubmission.
“We are deeply disappointed with this result, and this is an unfortunate day for patients suffering from anemia of CKD in the United States,” said Enrique Conterno, Chief Executive Officer, FibroGen. “Roxadustat is changing the lives of patients around the world, and we and our partner AstraZeneca will discuss next steps in the U.S.”
Roxadustat is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) adult patients and has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s committee responsible for human medicines. The European Commission decision is expected by the end of August.
- Interim analysis showed positive preliminary results for maintaining patients without mechanical ventilation and reducing the mortality rate, with shortened time to recovery and hospitalization duration
- A reduction in key pro-inflammatory cytokines and chemokines critically involved in cytokine release syndrome (CRS) was observed in patients treated with plonmarlimab compared to placebo
- Plonmarlimab treatment was well tolerated with no significant safety concerns in patients with severe COVID-19
- I-Mab plans to continue advancing the study in the U.S. and begins to explore other CRS-related opportunities
Southwest Airlines Co became the first big U.S. carrier to warn of a hit from the more infectious Delta variant of the coronavirus on Wednesday, saying it may not be profitable in the current quarter.
Shares of the company were down 2% in premarket trading as it said the spread of the variant had hit bookings and increased cancellations in August.
The profit warning marked a u-turn from the airline's upbeat statement last month that it would remain profitable for the rest of 2021. It also dragged down shares of rivals Delta Air Lines Inc, American Airlines Group Inc and United Airlines more than 1% each.
The rapid surge in cases of the variant has pushed U.S. hospitalizations to a six-month high, prompting governments in areas such as Hawaii to re-impose restrictions and threatening a recovery in travel demand.
Budget carrier Southwest had been one of the biggest beneficiaries of easing coronavirus curbs as it mainly caters to the domestic market.
The carrier on Wednesday also forecast its third-quarter operating revenue to be down 15% to 20% versus 2019, a cut of about three to four points from its prior outlook issued just three weeks ago.(https://bit.ly/3s94erL)
But it maintained its unit cost outlook for the quarter.
Last week, Frontier Airlines also lowered its third-quarter forecast and warned the Delta variant was hurting demand.
Southwest shares were trading at $49.85. They have risen 9.7% this year on hopes of a recovery in travel demand, but underperformed the benchmark S&P 500 index's 18.1% rise.
The Lambda variant of the coronavirus, first identified in Peru and now spreading in South America, is highly infectious and more resistant to vaccines than the original version of the virus the emerged from Wuhan, China, Japanese researchers have found.
In laboratory experiments, they found that three mutations in Lambda's spike protein, known as RSYLTPGD246-253N, 260 L452Q and F490S, help it resist neutralization by vaccine-induced antibodies.
Two additional mutations, T76I and L452Q, help make Lambda highly infectious, they found.
In a paper posted on Wednesday on bioRxiv ahead of peer review, the researchers warn that with Lambda being labeled a "Variant of Interest" by the World Health Organization, rather than a "Variant of Concern," people might not realize it is a serious ongoing threat.
Although it is not clear yet whether this variant is more dangerous than the Delta now threatening populations in many countries, senior researcher Kei Sato of the University of Tokyo told Reuters he believes "Lambda can be a potential threat to the human society."
The US Centers for Disease Control and Prevention issounding the alarm on a rare illnessthat was previously only seen in tropical climates, particularly South Asia and northern Australia.
Now, two people are dead and two have recovered after being infected with melioidosis — a disease that had never before been detected on contiguous US soil. Melioidosis has now been seen in Georgia, Kansas, Texas and Minnesota, LiveScience reported. The only other known cases of melioidosis in the US were in the Virgin Islands and Puerto Rico in the Caribbean.
None of the four patients claimed to have traveled outside the country prior to becoming sick between March and July of this year.
The CDC “believes the most likely cause is an imported product (such as a food or drink, personal care or cleaning products or medicine) or an ingredient in one of those types of products,” according to the statement released Monday.
Investigators have taken more than 100 samples of soil, water and common products used in and around each patient’s home in order to discover a link between the four cases — but have found no common source thus far. However, genome sequencing of the bacteria has revealed that the four cases are likely somehow related, the CDC added.
About a dozen cases of melioidosis are seen each year in Americans, nearly all of which can be attributed to travel. This is the first time doctors are seeing the illness seemingly originate within the contiguous US.
Caused by the bacterium Burkholderia pseudomallei, melioidosis can take several weeks to set in after exposure to the pathogen. Symptoms include cough and shortness of breath, fatigue, nausea, vomiting, intermittent fever and body rashes, the CDC wrote in a message to physicians on how to spot the illness.
Risk factors for developing the disease include diabetes, liver or kidney disease, chronic lung disease, cancer or another condition that weakens the immune system, the CDC warned.
Melioidosis survivor Lylah Baker, 4, spent a month in intensive care at a Dallas hospital after becoming sick in May, and suffered brain damage as a result.Gofundme
One of the known cases of melioidosis — involving a 4-year-old girl — was recently publicized in Texas. Preschooler Lylah Baker had no known risk factors for the illness when she was sickened in May. Lylah spent a month in the intensive care unit of Children’s Medical Center Dallas, requiring a ventilator and eventually suffering brain damage, according to the Dallas Morning News.
“She was a healthy, typical little girl about to start pre-K in the fall — no underlying health issues previously. I mean just nothing,” Ashley Kennon, the child’s aunt, told the newspaper. “So it was definitely a major surprise to everybody not knowing where [the bacteria] came from.”
Lylah is convalescing at Our Children’s House Dallas.
The CDC is urging doctors to be aware of melioidosis symptoms regardless of their patients’ locations and travels.
Researchers at Cambridge University in the UK are trialling an artificial intelligence system that they think could spot the signs of dementia after a single brain scan.
The team – led by Prof Zoe Kourtzi of the university and Alan Turing Institute – told the BBC that the AI could make it possible to start treatment earlier to slow down progression of Alzheimer’s disease and other forms of dementia.
The technology could be used to spot patients who are likely to have a slow decline in cognition and memory, and those that could have more rapid progression.
At the moment, it can take several brain scans and a battery of other cognitive tests to diagnose dementia, a process that can take between four and 12 weeks depending on waiting lists, according to the Alzheimer’s Society.
The AI has been trained using thousands of brain scans from patients with dementia patients, and uses an algorithm to identify patterns that even expert neurologists cannot see, according to the BBC report.
In preclinical testing it has been able to diagnose dementia years before symptoms develop, and when there is no obvious signs of damage on a scan.
Around 500 patients will be enrolled into a clinical trial of the AI at Addenbrooke’s Hospital in Cambridge and other memory clinics across the UK led by consultant neurologist Dr Tim Rittman.
Prof Kourtzi is also director of the Early Detection of Neurodegenerative diseases (EDoN) initiative, which recently secured $2 million in funding from the US Alzheimer’s Drug Discovery Foundation (ADDF) to develop a digital “toolkit” of apps and wearables to detect the very earliest stage of dementia.
The main thrust of the project is to develop machine learning models to identify patterns of early disease specific to different neurodegenerative diseases.
“Global efforts to tackle the diseases that cause dementia are currently hamstrung by our inability to detect them early enough,” according to Kourtzi.
“Digital technology holds enormous potential to put us on the front foot when it comes to identifying diseases like Alzheimer’s.”
